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FDA 510(k)

STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA

K-Number: K944372 · 1995-02-08

ApplicantSolarcare, Inc.
Decision Date1995-02-08
Product CodeJXN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA is the device name listed in this FDA 510(k) record. The listed applicant is Solarcare, Inc.. It received FDA 510(k) clearance on 1995-02-08 under 510(k) number K944372. The device is classified under product code JXN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA?

STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA is a medical device that received FDA 510(k) clearance on 1995-02-08. The listed applicant is Solarcare, Inc.. The 510(k) number is K944372.

When did STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA receive FDA 510(k) clearance?

STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA received FDA 510(k) clearance on 1995-02-08, under 510(k) number K944372.

Who is the listed applicant for STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA?

The FDA 510(k) record lists Solarcare, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA?

The FDA product code for STC DIAGNOSTIC AUTO-LYTE PROPOXYPHENE EIA is JXN.

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Other records listing Solarcare, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934775STC COCAINE METABOLITE EIAK941496SOLARCARE TOTAL PROTEIN MICRO-PLATE ASSAYK941497SOLARCARE ALANINE AMINOTRANSFERASE MICRO-PLATE ASSAYK934376STC DIAGNOSTICS AUTO-LYTE BARBITURATES EIAK933327HISTOFREEZER

Related Devices (Code: JXN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K122752FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARDBranan Medical Corp.K111363PPX REAGENT, PPX CALIBRATORS, PPX QC MATERIALMedica Corp.K043303ONLINE DAT PROPOXYPHENE PLUSRoche Diagnostics Corp.K040445ACON PPX ONE STEP PROPOXYPHENE TEST STRIP AND ACON PPX STEP PROPOXYPHENE TEST DEVICEACON Laboratories, Inc.K030835'RAPID ONE' - PROPOXYPHENE TESTAmerican Bio Medica Corp.K023795PROPOXYPHENE ENZYME IMMUNOASSAY, CATALOG #0120 (500 TEST KIT), #0121 (5000 TEST KIT)Lin-Zhi International, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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